Subject matter experts take on your quality-related queries
THIS MONTH'S FIRST QUESTION
Under ISO 9001:2015, how specific must you be when stating your
interested parties? Can you simply put "customers, stakeholders,
employees and suppliers," for example? Or is it better to list the names
of organizations and individuals? What is the most eﬀective way of
obtaining this information? How should it be diagrammed?
OUR RESPONSE
Identifying interested parties, or stakeholders, is a
new requirement in ISO 9001:2015. The requirement is
included in clauses of the standard that address:
+ Understanding the needs and expectations of interested
parties (clause 4.2).
+ Quality management system (QMS) scope (clause 4.3).
+ Quality policy (clause 5.2.2).
+ Measurement traceability (clause 7.1.6).
+ Requirements for products and services (clause 8.2.3).
+ Design and development planning (clause 8.3.2).
+ Management review (clause 9.3.2).
Clause 6.1.1 (risks and opportunities) indirectly includes
interested parties by referring to clause 4.2.
Understanding the needs and expectations of interested
parties can be accomplished through several approaches
such as brainstorming and expert judgement. Analyzing
contractual documents can reveal useful information, and
so can meetings and focus groups.
Where to start
The first step to addressing the interested parties requirement is to identify groups that may be relevant to your
QMS. Also consider regulatory agencies, shareholders, distributors, retailers, business partners, financial institutions,
business owners and the general public.
Within these groups, there may be specific organizations
or even individuals that are more relevant to your QMS than
others. Because needs and expectations may differ from
one organization to another, you should go beyond identifying groups and identify specific organizations that are
relevant to your QMS.
Review contracts and purchase orders, and brainstorm with
your corporate legal, corporate communications, purchasing,
regulatory compliance and quality departments to identify
8 QP
February 2018 ❘ qualityprogress.com
additional organizations. Your HR and quality departments also
may be helpful in identifying relevant internal groups. This list
can become long-the key is to keep it manageable.
To identify the most relevant interested parties, consider
using 2x2 matrixes such as power/interest, power/inﬂuence
or inﬂuence/impact. After you have your list, it's helpful to
associate each interested party with the specific ISO 9001
clause (listed earlier) it may inﬂuence.
Resources
Additional guidance can be found in resources such as
Quality Progress, Nancy R. Tague's The Quality Toolbox and
the Project Management Institute's A Guide to the Project
Management Body of Knowledge (PMBOK Guide). Online
searches that include "ISO 9001:2015 interested parties" and
"stakeholder analysis" will yield additional guidance.
Information management
The information obtained during this effort can be managed
with spreadsheets or tables. Understand who will use the
information and determine the best way to summarize and
share it. Although ISO 9001:2015 does not require a procedure for addressing interested parties, it may be beneficial to
document the process so it can be repeated later when information regarding the needs and expectations of interested
parties is updated.
Finally, consult with your ISO 9001 registrar. A registrar
can provide information about how it will assess compliance
to the interested parties requirement. Ultimately, you should
design an approach that makes good business sense and
provides value to your QMS.
This response was written by Ken Cogan, project manager,
Maxtena Inc., Rockville, MD.

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